U.S. patent number 5,041,085 [Application Number 07/485,269] was granted by the patent office on 1991-08-20 for percutaneous lockable sleeve catheter.
This patent grant is currently assigned to Cook Incorporated. Invention is credited to Thomas A. Osborne, Fred T. Parker, John D. Roll.
United States Patent |
5,041,085 |
Osborne , et al. |
August 20, 1991 |
Percutaneous lockable sleeve catheter
Abstract
A lockable sleeve drainage catheter is disclosed for
percutaneous insertion into a patient and drainage of fluid
therefrom. The drainage catheter includes a flexible distal end
that is preformed for retaining the distal end of the catheter that
is inserted in the patient. For insertion, the distal end is
straightened with the use of a stiffening cannula that is inserted
through the hollow passageway of the catheter. When the catheter is
inserted in the patient, the stiffening cannula is removed, and a
flexible tension member positioned within the passageway of the
catheter is drawn to position the distal end in the desired
retention configuration. A lockable sleeve positioned at the
proximal end of the catheter draws the flexible tension member
through the passageway of the elongated member tube to position the
distal end in the retention configuration. The catheter also
includes a locking collar at the proximal end of the elongated
member tube having an annular recess formed therein. The distal end
of the lockable sleeve includes an annular step for engaging the
recess of the collar and locking the sleeve in a fixed position
relative to the elongated member tube of the catheter. When fully
extended and locked, the sleeve and elongated member form a fluid
tight interconnection. A Luer lock connector is affixed to the
proximal end of the sleeve for connection to a drainage collection
system.
Inventors: |
Osborne; Thomas A.
(Bloomington, IN), Parker; Fred T. (Unionville, IN),
Roll; John D. (Rockford, IL) |
Assignee: |
Cook Incorporated (Bloomington,
IN)
|
Family
ID: |
23927521 |
Appl.
No.: |
07/485,269 |
Filed: |
February 26, 1990 |
Current U.S.
Class: |
604/541;
604/95.04; 604/910; 604/178; 604/171 |
Current CPC
Class: |
A61M
25/0041 (20130101); A61J 15/0023 (20130101); A61M
25/01 (20130101); A61J 15/0038 (20130101); A61M
25/04 (20130101); A61J 15/0007 (20130101); A61M
2025/0163 (20130101) |
Current International
Class: |
A61J
15/00 (20060101); A61M 25/00 (20060101); A61M
25/01 (20060101); A61M 25/02 (20060101); A61M
25/04 (20060101); A61M 031/00 () |
Field of
Search: |
;604/93,95,164,165,171,174,178,280,283,905 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Willis-Oglesby Percutaneous Gastrostomy Set", Cook Incorporated,
Bloomington, Ind., 1984. .
"Cook-Cope Type Loop Drainage Sets", Cook Incorporated,
Bloomington, Ind., 1983. .
Roll et al., "Simplification of the Cope Loop Catheter," Seminars
in Interventional Radiology, vol. 4, No. 1, Mar. 1987, p.
46..
|
Primary Examiner: Yasko; John D.
Assistant Examiner: Cermak; Adam J.
Attorney, Agent or Firm: Godlewski; Richard J.
Claims
What is claimed is:
1. A medical device comprising:
an elongated member for insertion into a body and having a distal
end, a proximal end, and a passageway extending longitudinally
therebetween, said proximal end having a recess therein, said
distal end being formed to be positioned into a predetermined
configuration;
an elongated sleeve having a distal end, a proximal end, and a
passageway extending therebetween, said proximal end of said
elongated member being positioned and longitudinally moveable
within said sleeve passageway, said sleeve having a projection
extending into said sleeve passageway about said distal end thereof
and engageable with said recess to position longitudinally said
sleeve relative to said elongated member; and
a flexible tension member extending along said elongated member and
said sleeve, fixedly positioned about said proximal end of said
sleeve, and positioned and drawable about said distal end of said
elongated member to position said distal end of said elongated
member into said predetermined configuration.
2. The medical device of claim 1 further comprising a collar
including said recess and positioned about said proximal end of
said elongated member.
3. The medical device of claim 2 wherein said recess in said collar
comprises an annular channel extending circumferentially in an
outer surface of said collar.
4. The medical device of claim 3 wherein said projection comprises
an annular ridge extending into said sleeve passageway about said
distal end thereof and sized to fit tightly in said annular
channel.
5. The medical device of claim 3 wherein said projection comprises
an annular step at said distal end of said sleeve sized to snap fit
into said annular channel and having an opening therein having a
dimension less than a maximum outside dimension of said collar in
said annular channel.
6. The medical device of claim 1 further comprising a connector
positioned about said proximal end of said sleeve.
7. The medical device of claim 1 wherein said elongated member
includes a plurality of ports about said distal end thereof, said
flexible member extending in said passageway of said elongated
member and external thereto between first and second of said ports
and drawable with said sleeve to position said distal end of said
elongated member into said predetermined configuration.
8. In a catheter including a flexible elongated member having a
distal end, a proximal end, a passageway extending longitudinally
between said ends, and first and second draw ports positioned about
said distal end and also including a flexible tension member
passing through at least one of said draw ports or, alternatively,
attached about said distal end and drawable to position said distal
end of said elongated member into a predetermined
configuration;
the improvement comprising:
a lockable sleeve having a distal end, a proximal end, and a
passageway therebetween, said proximal end of said elongated member
being movable within said passageway of said sleeve, said flexible
tension member extending through said passageway of said elongated
member and said sleeve and being attached to said sleeve;
a recess positioned about a proximal end of said elongated member
and engageable with a projection received therein to longitudinally
position said elongated member relative to said sleeve; and
said sleeve also including said projection positioned about said
distal end and extending radially in said passageway thereof.
9. The catheter of claim 8 wherein said improvement further
comprises a collar positioned about said proximal end of said
elongated member and including said recess therein.
10. The catheter of claim 8 wherein said recess comprises a groove
positioned circumferentially around said collar.
11. The catheter of claim 10 wherein said projection comprises an
annular ridge sized to tightly fit within said groove.
12. A drainage catheter comprising:
a flexible elongated member for insertion into a body of a patient
and having a distal end, a proximal end, and a hollow passageway
extending longitudinally therebetween, said distal end being formed
to be positioned into a predetermined configuration and having a
plurality of side ports including first and second draw ports;
a collar positioned about said proximal end of said elongated
member and having an annular recess extending circumferentially in
an outer surface thereof;
a lockable sleeve having a distal end, a proximal end, and a
passageway extending therebetween, said proximal end forming an
annular step extending into said sleeve passageway and engageable
with said annular recess to position longitudinally said sleeve
relative to said elongated member, said annular step being sized to
fit tightly in said annular recess; and
a flexible tension member extending through said passageway of said
elongated member and said sleeve and said first and second draw
ports and also exterior to elongated member between said first and
second draw ports, fixedly positioned about said proximal end of
said sleeve and drawable through said first and second draw ports
to position said distal end of said elongated member in said
predetermined configuration.
13. The method of percutaneously draining fluid from a cavity of a
patient with a medical device comprising an elongated member having
a distal end, a proximal end, and a passageway extending
longitudinally therebetween, at least the distal end being for
insertion, into the cavity of the patient; and means extending
between the distal and proximal ends and drawable to reconfigure
the distal end into a desired configuration; the device further
comprising an elongated sleeve having distal and proximal ends with
a passageway therebetween, the sleeve being positioned about and
longitudinally moveable with respect to and adjacent to the
proximal end of the elongated member; the drawable means being
attached to the sleeve; and the elongated member within the sleeve
and the interior of the sleeve having cooperating parts associated
therewith for engaging the sleeve and the elongated member together
when moved relative to one another to an engaging or interlocking
position, comprising the steps of:
percutaneously inserting the distal end of the elongated member
into the cavity of the patient;
moving the sleeve relative to the elongated member to the engaging
or interlocking position; and
connecting the sleeve to a fluid collection system.
14. The method of claim 13 further comprising the step of
reconfiguring the distal end of the elongated member to the desired
configuration.
15. The method of claim 14 wherein the step of reconfiguring
includes drawing the drawable means in cooperation with moving the
sleeve relative to the elongated member.
16. The method of claim 15 further comprising the step of engaging
the cooperating parts of the sleeve and the elongated member to the
engaging or interlocking position.
17. The method of claim 16 further comprising the step of forming a
fluid-tight seal between the sleeve and the elongated member when
the cooperating parts of the sleeve and the elongated member are in
the engaging or interlocking position.
18. A medical device comprising an elongated member having a distal
end, a proximal end, and a passageway extending longitudinally
therebetween, at least the distal end being for insertion into a
patient; and means extending between the distal and proximal ends
and positioned and drawable to reconfigure the distal end into a
desired configuration; characterized in that the device further
comprises an elongated sleeve having distal and proximal ends with
a passageway therebetween, the sleeve being positioned about and
longitudinally moveable with respect to and adjacent to the
proximal end of the elongated member; in that the drawable means is
attached to the sleeve; and in that the elongated member within the
sleeve and the interior of the sleeve have cooperating parts
associated therewith for engaging the sleeve and the elongated
member together when moved relative to one another to an engaging
or interlocking position.
19. A device according to claim 18, characterized in that means are
provided for clamping the drawable member relative to the proximal
end of the sleeve; and in that the relative movement of the distal
end of the sleeve towards the proximal end of the elongated member
causes the drawable means to reconfigure the distal end of the
elongated member into the desired configuration.
20. A device according to claim 18, characterized in that the
cooperating parts comprise an annular ridge on the interior surface
of the sleeve, and a cooperating recess associated with the
exterior surface of the longitudinal member, the relative movement
required to bring the ridge and the recess into cooperative
engagement serving to provide the required movement of the drawable
means.
21. A method of locating part of a medical device in a patient,
said method comprising the steps of inserting at least the distal
end of an elongated member in a cavity of the patient, and applying
tension to a drawable member extending along the elongated member
in order to reconfigure the distal end into a desired configuration
thereby locking the distal end within the cavity, characterized in
that the proximal end of the drawable member is attached to a
sleeve longitudinally slidably positioned about the proximal end of
the elongated member, and in that the tension is applied by moving
the sleeve relative to the elongated member to a position in which
the sleeve and elongated member engage or interlock.
Description
TECHNICAL FIELD
This invention relates to catheters and particularly to a catheter
having a lockable sleeve for drawing the distal end into a
predetermined configuration.
BACKGROUND OF THE INVENTION
Suprapubic catheterization of the bladder is used to drain the
bladder after surgery or when the genitourinary system is plugged
by an obstruction. Other percutaneously inserted catheters are also
used to drain the kidney or biliary system as well as to drain
abscesses, other sites of fluid collection and other viscera. Still
other percutaneously inserted catheters are gastrostomy feeding
tubes.
These catheters are introduced into the patient by means of a large
hypodermic needle or trocar which typically pierces the abdominal
wall. A wire guide is inserted through the needle, which is then
removed. The catheter tube with a stiffening cannula positioned
therein is then passed over the wire guide into the cavity. The
cannula and wire guide are withdrawn, leaving the catheter in the
desired cavity. With respect to the bladder, the advantage of this
technique is that irrigation and infection of the urinary tract is
minimized. However, one problem with these catheters is that the
catheter can be easily pulled out by movement of the body or by the
emptying of, for example, the bladder. Another problem is that side
ports at the distal end of the catheter may be inadvertently drawn
into the abdominal cavity creating potential for severe
infections.
Various catheters have been developed with so-called pigtail loops
at their distal ends which both ensures drainage of the cavity and
prevents accidental removal therefrom. The pigtail loop is
tightened by pulling on the proximal end of a flexible tension
member which extends through the catheter. The proximal end of this
tension member is held in place by any one of a number of retention
means. In U.S. Pat. No. 1,207,479 to Bisgaard, the proximal end of
the tension member is held in place by axially placing a hollow cap
into or over the proximal end of the catheter tube, thus trapping
the flexible tension member of which the protruding end may then be
cut.
In other catheter developed by one of the present inventors and
described in U.S. Pat. No. 3,924,677, the flexible tension member
is trapped between two or more hollow tubes, one of which is
slidably inserted axially into the other. A short length of the
flexible member is generally left hanging from the catheter tube so
that if the tension member becomes loose, it may be
retightened.
In a second generation of this flexible member catheter, an
external sleeve is slid over the flexible member protruding from
the side of the catheter tube of which the flexible member is then
wound around and tied about the sleeve.
Although well suited for its intended purpose, the physician is
required to grasp and pull on the flexible tension member and to
either secure or tie it about the proximal end of the catheter.
Such a flexible tension member left exposed at the proximal end
allows the patient to untie the member. As a result, the assistance
of hospital personnel is required to retie the member. Furthermore,
when the flexible tension member is inadvertently released, the
retaining loop at the distal end is released with the possibility
of the catheter being withdrawn from the patient.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is
achieved in an illustrative lockable sleeve medical device such as
a drainage catheter for insertion into a cavity or passageway of a
patient. The lockable sleeve at the proximal end of the catheter
draws the distal end of the catheter into a predetermined
configuration, such as a pigtail loop, for retaining the catheter
in the cavity or passageway of the patient. The catheter comprises
a flexible elongated member, such as a flexible polymer material
tube, having distal and proximal ends with a hollow passageway
therebetween. Positioned about the distal end of the elongated
member tube is a plurality of drainage ports for fluid to enter and
drain through the tube. Also positioned about the distal end are
first and second draw ports for positioning a flexible tension
member therethrough, which is drawn to position the distal end of
the tube into the predetermined configuration after the distal end
of the tube is inserted into the cavity or passageway of the
patient. When so positioned, the configured distal end prevents
retraction of the catheter from the patient.
The improvement over the prior art comprises a lockable sleeve
having a hollow passageway therein for receiving the proximal end
of the elongated member. The flexible tension member is attached to
the proximal end of the sleeve through the passageway of both the
sleeve and elongated member to draw the distal end of the elongated
member into the predetermined configuration. The sleeve also
includes a projection positioned about the distal end thereof and
extending into its passageway for engaging a recess in the proximal
end of the elongated member. The flexible tension member is drawn
by pulling the lockable sleeve longitudinally with respect to the
proximal end of the elongated member. When the sleeve is fully
extended to the proximal end of the elongated member, the
projection in the sleeve engages the recess at the proximal end of
the elongated member to fixedly position and lock the position of
the sleeve relative to the elongated member. As a result, the
distal end of the elongated member is drawn into the predetermined
configuration, which prevents retraction of the catheter from the
patient. Advantageously, the distal end of the elongated member is
drawn into the pigtail configuration without the physician having
to cut or tie the free end of the flexible tension member. Whereas
with the present invention, the distal end of the elongated member
is drawn into the desired configuration with the simple motion of
the physician pulling longitudinally on the sleeve with respect to
the elongated member.
To minimize, if not eliminate, the drainage of fluid between the
distal end of the sleeve and the proximal end of the elongated
member, a further improvement includes a collar having the recess
formed therein and positioned about the proximal end of the
elongated member. The recess comprises a groove or annular channel
extending circumferentially in the outer surface of the collar.
To further secure and minimize fluid drainage from around the
proximal end of the elongated member and the distal end of the
sleeve, the sleeve projection comprises an annular ridge that
extends into the sleeve passageway at the distal end thereof and is
sized to fit tightly in the annular channel of the collar.
Alternatively, the projection comprises an annular step at the
distal end of the sleeve that is also sized to snap fit into the
annular channel of the collar. Furthermore, the dimension of the
opening through the annular step is less than the maximum outside
surface dimension of the annular channel to provide an extremely
tight and leak resistant fit. This further enhances the ability of
the catheter to minimize fluid drainage at the joined
interconnection of the sleeve and elongated member.
A connector is suitably attached about the proximal end of the
sleeve for connection to a fluid collection system. In addition,
the flexible tension member is attached to the proximal end of the
sleeve and extends through at least one of the draw ports at the
distal end of the elongated member to draw the distal end of the
elongated member into the predetermined configuration. A plurality
of side ports at the distal end of the elongated member allow entry
of the fluid into the tube and drainage through the passageway to
the collection system.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 depicts a lockable sleeve drainage catheter of the present
invention;
FIG. 2 depicts a partially-sectioned view of the catheter of FIG. 1
inserted in the bladder of a patient;
FIG. 3 depicts a partially-sectioned view of the catheter of FIG. 2
in a locked position;
FIG. 4 depicts an alternative embodiment of the distal end of the
catheter for use in the biliary system of a patient; and
FIG. 5 depicts a second alternative embodiment of the distal end of
the catheter for use as a gastrostomy feeding tube.
DETAILED DESCRIPTION
Depicted in FIG. 1 is a partially-sectioned view of an illustrative
lockable sleeve drainage catheter 101 in a relaxed and unlocked
position prior to percutaneous insertion into a bladder.
Depicted in FIG. 2 is catheter 101 with stiffening cannula 126
inserted into bladder 102 over wire guide 103. Before insertion of
catheter 101, a thinwall needle with a stylet inserted therein (not
shown) is percutaneously inserted through abdominal wall 130 into
the bladder using a well-known technique. The stylet is removed,
and the wire guide is inserted through the needle into the bladder.
The needle is then removed with the wire guide left in place. A
dilator is commonly used over the wire guide to increase the size
of the puncture site. Drainage catheter 101 with a stiffening
cannula inserted therein is then inserted over the wire guide into
bladder 102 as shown.
As shown in FIGS. 1 and 2, catheter 101 includes an elongated
member 104 and a lockable sleeve 110, formed from flexible plastic
material tubes having different diameters. Flexible member 104 has
a tapered distal end -05, a flared proximal end 106, and a hollow
longitudinal passageway 107 therebetween. Distal end 105 is
preformed into a predetermined configuration such as a well-known
pigtail. A plurality of side ports 108 are formed through the wall
of the elongated member about the distal end thereof for fluid such
as urine to enter and drain through passageway 107. Passageway 107
also forms an opening 109 at the very distal end of the elongated
member. Opening 109 permits the insertion of the catheter into a
patient over the wire guide and also allows further drainage of
fluid into passageway 107. However, a stiffening cannula is
normally inserted through passageway 107 of the catheter to
straighten the preformed distal end for percutaneous insertion over
the wire guide into the bladder. When the catheter has been
inserted in the bladder, the stiffening cannula and wire guide are
then removed from passageway 107.
Similarly, lockable sleeve 110 has a tapered distal end 111, a
proximal end 112, and a hollow longitudinal passageway 113
therebetween. As previously indicated, both the elongated member
and the lockable sleeve are formed from flexible plastic material
tubes. By way of example, elongated member 104 is a 10.2 French
polyurethane material tube approximately 32 cm in length, whereas
lockable sleeve 110 is a 20 French polyurethane material tube
approximately 6.5 cm in length. As shown, flared proximal end 106
of the elongated member tube and locking collar 114 affixed
thereabout are positioned within sleeve passageway 113 and are
longitudinally moveable therein.
The generally cylindrically-shaped locking collar includes two
truncated cones 127 and 128 with beveled surfaces 115 and 116
facing the opposite ends of the collar. Base surfaces 117 and 118
of respective cones 127 and 128 and the outside surface 119 of the
collar therebetween form an annular recess, such as a groove or
channel, in the collar. Lockable sleeve 110 is longitudinally
moveable over locking collar 114.
Distal end 111 of the lockable sleeve includes a projection 120,
such as an annular ridge or step, which extends into passageway 113
to engage the annular recess of locking collar 114. As shown,
annular step 120 at the tapered distal end 111 of the sleeve is
sized to snap fit into the annular recess of collar 114 when the
distal end of the sleeve is longitudinally moved over beveled
surface 115. As a result, annular step 120 snaps into the annular
recess of the collar. The minimum dimension or diameter of
passageway 113 through annular step 120 is less than the maximum
dimension or diameter of outside surface 119 of the collar in the
annular recess. The two dimensions are sized to form a tight fit
between the annular step and recess when interconnected, which
prevents the passage of fluid through the interconnection. Beveled
surface 116 of the collar and flared distal end 106 of the tube
further prevent the passage of fluid through the
interconnection.
The drainage catheter further includes flexible tension member 121
that passes through passageways 107 and 113 of elongated member
tube 104 and lockable sleeve 110, respectively. Draw ports 122 and
123 are formed through the wall of the elongated member tube near
drain ports 108. The flexible tension member passes from within
passageway 107 through draw port 122 to the exterior of the
elongated member and back into interior passageway 107 through draw
port 123. The flexible tension member forms a loop through the draw
ports, which is drawable to position the distal end of the
elongated member tube into the desired pigtail configuration. The
ends of the flexible tension member are secured to proximal end 112
of the lockable sleeve between the wall of the sleeve and the
outside barbed surface of a well-known Luer lock connector 124. The
flexible tension member, such as commercially available 4-0 Tevdek
suture, is further secured between the two surfaces using, for
example, Locktite 401 sealing compound.
When distal end 105 of elongated member tube 104 is fully extended
for insertion into the bladder, lockable sleeve 110 is in a fully
forward and unlocked position with the flared proximal end 106 of
the tube positioned next to connector 124. Commonly, the Luer lock
connector is formed with a taper at the distal end thereof. As a
result, the flared proximal end 106 receives the tapered end of the
Luer lock connector. The flared end fits against the wall of the
sleeve to prevent the passage of fluid and flexible tension member
therebetween.
Depicted in FIG. 3 is a partially-sectioned view of drainage
catheter 101 with sleeve 110 in a fully drawn and locked position
and distal end 105 positioned in the pigtail configuration. The
pigtail configuration at the distal end of elongated member tube
104 acts as a retention device to prevent the catheter from being
removed from the bladder. In the locked position, the sleeve has
been longitudinally moved along the proximal end of the elongated
member tube to engage annular step 120 with outside surface 119 in
annular recess of collar 114. When the sleeve is pulled, the
flexible tension member 121 is drawn through and out of elongated
member passageway 107 to close the loop between draw ports 122 and
123, thereby positioning the distal end of the elongated member
tube into the pigtail configuration. Retention disk 129 is applied
to the outside surface of abdominal wall 130 around the elongated
member with tie 125 to more securely position the drainage catheter
in the patient. Retention disk 129 is commercially available from a
number of sources such as Cook Incorporated, Bloomington, Ind.
Flexible elongated member tube 104 may also be bent to run
alongside the patient's body using a 90.degree. retention disk also
available from Cook Incorporated.
Depicted in FIG. 4 is an alternative embodiment of the distal end
of the drainage catheter. In this particular embodiment, distal end
401 of elongated member 402 of the catheter has been preformed into
a well-known configuration for retaining the distal end in the
biliary system of a patient. A plurality of drainage ports 403 and
404 have been formed about the distal end and the main body of
elongated member 402, respectively.
Depicted in FIG. 5 is a second alternative embodiment of the distal
end of the elongated member portion of the drainage catheter. In
particular, distal end 501 of elongated member tube 502 has been
formed into a pigtail configuration with the distal end extending
from pigtail curl 503. Such a configuration is suitable for use as
a percutaneous inserted gastrostomy feeding tube.
It is to be understood that the above-described drainage catheter
is merely an illustrative embodiment of the principles of this
invention and that other apparatus and catheters may be devised by
those skilled in the art without departing from the spirit and
scope of this invention. In particular, the distal end of the
catheter may be preformed into any desired configuration for
positioning and retaining the distal end of the catheter in any
part of a patient's body. Furthermore, the lockable sleeve of the
drainage catheter may be designed with an 0-ring seal and the like
for preventing fluid from passing through the joined
interconnection of the sleeve and elongated member. Similarly, a
single finger-like projection may extend into a recess formed in
the proximal end of the elongated member tube. However, the
illustrative embodiment illustrates a drainage catheter which is
easily manipulated by the physician without having to tie the
flexible tension member. Once in the locked position, the catheter
maintains a closed system for which fluid may be drained from the
patient. Furthermore, one end of the flexible tension member may be
attached in any one of a number of well-known ways to the distal
end of the elongated member and drawable through one or more draw
ports for positioning the distal end and in the desired
position.
* * * * *